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Effect of Diet on Intestinal Gas Production and Evacuation in Healthy Subjects and Flatulent Patients

NCT01291446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-03-23

No results posted yet for this study

Summary

Background Some patients complain of excessive evacuation, which may become socially disabling (Azpiroz F \& Malagelada J-R, 2005). However, there no systematic investigation on the range of gas evacuation in healthy subjects and in subjects complaining of flatulence under basal conditions and in response to a high-flatulogenic diet (Azpiroz F \& Levitt DG, 2009).

Hypothesis Patients complaining of excessive passage of gas per anus have more intestinal gas production and more anal gas evacuation during basal conditions and in response to a high flatulogenic diet than healthy subjects. This abnormality is related to the differences in colonic microflora.

Objectives

* To determine the normal range of intestinal gas evacuation under basal conditions and in response to a high flatulogenic diet.
* In patients complaining of flatulence, to determine whether intestinal gas evacuation under basal conditions and in response to a high flatulogenic diet is increased.
* To identify differences in the microbiota pattern in subjects with normal and excessive anal gas evacuation.
* In patients complaining of flatulence, to determine the segmental distribution of intestinal gas after a diet challenge.

Methods Healthy subjects (n=20) and patients complaining of flatulence (n=30) will undergo a 3-day basal phase on their current diet and a 3-day challenge phase on a high-flatulogenic diet; patients will be followed-up for 7 days on a low-flatulogenic diet. The following g measurements will be performed: daily measurement of the number of anal gas passages with an event marker, continuous recording of anal gas evacuation in the laboratory using an electronic leakage-free gas collection system, colonic flora analysis by fecal sampling, and segmental gas distribution in the gut by abdominal computer tomography (CT) imaging.

Relevance These studies will allow to develop the normal range of anal gas evacuation during basal conditions. Furthermore, a provocative test will be developed for the diagnosis of excessive gas production in patients complaining of flatulence. This data will allow a proper diagnosis of these patients and will pave the path for a rational management and for the development of evidence-based treatment strategies. This pilot study will allow a proper design with adequate sample size calculation in future interventional studies.

Conditions

  • Flatulence

Interventions

DIETARY_SUPPLEMENT

High flatulogenic diet

During 3-days subjects will consume a diet with high content of fermentable residues

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Fernando Azpiroz, MD, PhD · Vall d'Hebron University Hospital, Barcelona 08035, Spain

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-10-31
Completion
2011-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01291446 on ClinicalTrials.gov